- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02495675
Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects (HDWOBSS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in carbone dioxyde arterial pressure. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.
The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing among healthy subjects. The investigators will evaluate the baseline status in room air, and then compare it with four different levels of flow. The primary endpoint will be the work of breathing.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Quebec
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Québec, Quebec, Canada, G1V4G5
- Rekruttering
- Centre de recherche de l'IUCPQ
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Kontakt:
- François Lellouche, MD, PhD
- Telefonnummer: 3298 418-656-8711
- E-mail: francois.lellouche@criucpq.ulaval.ca
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy subjects
- Written and informed consent
Exclusion Criteria:
- Pregnant or breastfeeding women;
- Subject enrolled in another study excluding co-enrolment;
- Cardio-vascular or respiratory disease;
- History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
- Subject feeling nauseous or under recent fed condition (<1h).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: No flow
Subjects will be spontaneously breathing in room air with no flow.
|
|
Eksperimentel: Conventional flow via nasal prongs
Subjects will be breathing with nasal prongs delivering 5 L/min of air (inspired fraction of oxygen: 0.21)
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Low flow of air delivered through conventional nasal prongs
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Eksperimentel: High flow nasal cannulas 20 L/min
Subjects will be breathing with high flow nasal cannulas delivering 20 L/min with an inspired fraction of oxygen of 0.21.
|
Comparison of different flow levels
Andre navne:
|
Eksperimentel: High flow nasal cannulas 40 L/min
Subjects will be breathing with high flow nasal cannulas delivering 40 L/min with an inspired fraction of oxygen of 0.21.
|
Comparison of different flow levels
Andre navne:
|
Eksperimentel: High flow nasal cannulas 60 L/min
Subjects will be breathing with high flow nasal cannulas delivering 60 L/min with an inspired fraction of oxygen of 0.21.
|
Comparison of different flow levels
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Work of breathing
Tidsramme: 10 minutes
|
Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome).
|
10 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Esophageal pressure-time product
Tidsramme: 10 minutes
|
Measured at the end of each period
|
10 minutes
|
Tidal Volume
Tidsramme: 10 minutes
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Measured at the end of each period
|
10 minutes
|
Comfort of breathing
Tidsramme: 10 minutes
|
Subjective evaluation at the end of each period
|
10 minutes
|
Blood gases
Tidsramme: 10 minutes
|
Arterial or capillary blood gases at the end of each period
|
10 minutes
|
Dyspnea
Tidsramme: 10 minutes
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Evaluation on a borg scale at the end of each period
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10 minutes
|
Respiratory Rate
Tidsramme: 10 minutes
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Measured at the end of each period
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10 minutes
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End-tidal carbon dioxide
Tidsramme: 10 minutes
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Measured at the end of each period
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10 minutes
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Heart rate
Tidsramme: 10 minutes
|
Measured at the end of each period
|
10 minutes
|
Oxygen saturation
Tidsramme: 10 minutes
|
Measured at the end of each period
|
10 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: François Lellouche, MD, PhD, Fondation IUCPQ
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IUCPQ-HDWOBSS
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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